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Complete Response Letter For Outlook’s Bevacizumab Is Both Straightforward And Elusive

Low On Cash, Rush Is On To Clarify US FDA’s Concerns

 
• By Mandy Jackson

Paralleling the challenges of the wet AMD market it hopes to enter, the CRL for Lytenava cites manufacturing issues, which Outlook Therapeutics feels it can easily address, as well as the need for confirmatory clinical evidence, which has left the firm scrambling for a meeting with FDA.

Close up cropped shot, face of senior woman eye looking straight, into distance.
Outlook will request at Type A meeting with the FDA to discuss the CRL • Source: Shutterstock

The complete response letter for Lytenava that Outlook Therapeutics, Inc. revealed on 30 August parallels in many ways the challenges of the wet age-related macular degeneration market that firm is trying to enter with its proprietary formulation of bevacizumab: It is both straightforward and elusive.

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US FDA’s Review Performance Held Steady Despite Stormy First Quarter

 
• By Bridget Silverman

Organizational turmoil has not yet affected reviews of novel agent applications, with Q1 2025 approvals coming in low, but the first quarter share of the entire year is variable.

Elevar/Hengrui’s Second US CRL A Bad Omen For Multiregional Trials In Asia-Dominant Cancers?

 
• By Dexter Jie Yan

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• By Sue Sutter

Acting Commissioner Sara Brenner rejected the company’s request for a hearing, saying the lack of an adequate and well-controlled trial showing tasimelteon's effectiveness in treating sleep-onset insomnia is “fatal to the application.”

Better Luck Next Year: US FDA CRLs May Be Rising, But Are Not The End Of The Story

 
• By Bridget Silverman

Prospects are promising for many of the 16 novel candidates that received complete response letters in 2024 after half of the 2023 CRL class was approved the following year.

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